FDA Approvals

New biosimilar for RA to save millionsFDA’s approval of a new biosimilar—the third FDA-approved biosimilar—stands to save the US healthcare system millions of dollars.
Abuse-deterrent opioid pain drug approvedFDA recently approved the only oxycodone with oral abuse-deterrent features.
EpiPen discounts offered after pricing flapAfter protests by patients, parents and Congressional representatives, Mylan said it would offer discounts on its epinephrine EpiPen Auto-Injector treatment to stop allergic reactions.
Game-changing depression drug on horizon
Game-changing depression drug on horizonFDA recently granted Breakthrough Therapy Designation for esketamine (Janssen Research & Development), an investigational medication to treat major depressive disorder with imminent risk for suicide.
New drug approved for chemotherapy nauseaFDA recently approved granisetron (Sustol, Heron Therapeutics) extended-release injection to prevent nausea and vomiting associated with repeat courses of chemotherapy.
AbbVie hep C drug combo enters marketIn an era when legislators, pharmacy benefit managers and others continue to protest the high cost of hepatitis C drugs, new drugs to treat the disease are welcomed. FDA recently approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira XR, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with cirrhosis. AbbVie already markets Viekira Pak, which competes with Harvoni and Sovaldi (Gilead Sciences).
Merck value rises after new Keytruda approvalMerck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.
New diabetes drug up against leading brandsFDA approved lixisenatide (Adlyxin, Sanofi-Aventis), a once-daily mealtime GLP-1 receptor agonist injection for type 2 diabetes, which will compete against the once-weekly pen dulaglutide (Trulicity, Eli Lilly) and the injectable liraglutide (Victoza, Novo Nordisk).
FDA approves drug for pregnant women with HIVFDA recently approved an expansion to the prescribing information for darunavir (Prezista, Janssen Therapeutics), to treat pregnant women with HIV.
New weight management pill available soonFDA recently approved the New Drug Application (NDA) for (lorcaserin HCl) CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a day dosing option for chronic weight management.